Apparatus and methods for treating congestive heart disease

ABSTRACT

Methods and apparatus are provided for treating congestive heart failure using a catheter having an inlet end configured for placement in the source of arterial blood such as the aorta, left ventricle or a femoral artery, and an outlet end having at least one conduit configured to be placed in the renal arteries. The catheter includes a lumen through which blood passes from the aorta or left ventricle directly to the renal artery, means for engaging the first conduit with renal artery. The means for engaging also may reduce backflow of blood into the abdominal aorta. The catheter preferably is configured to permit percutaneous, transluminal implantation. Methods of using and implanting the catheter are also provided.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.10/613,654, entitled “APPARATUS AND METHODS FOR TREATING CONGESTIVEHEART DISEASE,” filed Jul. 3, 2003 by Gad Keren et al, which is acontinuation of U.S. patent application Ser. No. 09/229,390 entitled“APPARATUS AND METHODS FOR TREATING CONGESTIVE HEART DISEASE,” filedJan. 11, 1999 by Gad Keren et al., the entire disclosures of which areincorporated herein by reference for all purposes.

FIELD OF THE INVENTION

The present invention relates to apparatus for treating congestive heartdisease by providing increased perfusion to the kidneys, therebyenhancing renal function.

BACKGROUND OF THE INVENTION

It has long been known that cardiac dysfunction induces a series ofevents that ultimately contribute to congestive heart failure (“CHF”).One such event is a reduction in renal blood flow due to reduced cardiacoutput. This reduced flow can in turn result in the retention of excessfluid in the patient's body, leading for example, to pulmonary andcardiac edema.

Chapter 62 of Heart Disease: A Textbook of Cardiovascular Medicine, (E.Braunwald, ed., 5th ed. 1996), published by Saunders, Philadelphia, Pa.,reports that for patients with CHF, the fall in effective renal bloodflow is proportional to the reduction in cardiac output. Renal bloodflow in normal patients in an age range of 20-80 years averages 600 to660 ml/min/m², corresponding to about 14 to 20 percent of simultaneouslymeasured cardiac output. Within a wide spectrum of CHF severity, renalblood flow is depressed to an average range of 250 to 450 ml/min/m².

Previously known methods of treating congestive heart failure anddeteriorating renal function in patients having CHF principally involveadministering drugs, including diuretics that enhance renal function,such as furosemide and thiazide, vasopressors intended to enhance renalblood flow, such as Dopamine, and vasodilators that reducevasoconstriction of the renal vessels. Many of these drugs, whenadministered in systemic doses, have undesirable side-effects.

In addition, for patients with severe CHF (e.g., those awaiting hearttransplant), mechanical methods, such as hemodialysis or leftventricular assist devices, may be implemented. Mechanical treatments,such as hemodialysis, however, generally have not been used forlong-term management of CHF.

Advanced heart failure (“HF”) requires the combination of potentdiuretics and severe restriction of salt intake. Poor patient complianceis a major cause of refractoriness to treatment. On the other hand, asrenal urine output decreases with reduced renal perfusion, in the eventof dehydration, the required diuretic dosages increase.

In view of the foregoing, it would be desirable to provide methods andapparatus for treating and managing CHF without administering high dosesof drugs or dehydrating the patient.

It further would be desirable to provide methods and apparatus fortreating and managing CHF by improving blood flow to the kidneys,thereby enhancing renal function.

It also would be desirable to provide methods and apparatus for treatingand managing CHF that permit the administration of low doses of drugs,in a localized manner, to improve renal function.

It still further would be desirable to provide methods and apparatus fortreating and managing CHF using apparatus that may be percutaneously andtransluminally implanted in the patient.

SUMMARY OF THE INVENTION

In view of the foregoing, it is an object of the present invention toprovide methods and apparatus for treating and managing CHF withoutadministering high doses of drugs or dehydrating the patient.

It is another object of this invention to provide methods and apparatusfor treating and managing CHF by improving blood flow to the kidneys,thereby enhancing renal function.

It is also an object of this invention to provide methods and apparatusfor treating and managing CHF that permit the administration of lowdoses of drugs, in a localized manner, to improve renal function.

It further is an object of the present invention to provide methods andapparatus for treating and managing CHF using apparatus that may bepercutaneously and transluminally implanted in the patient.

These and other objects of the present invention are accomplished byproviding a catheter having an inlet end configured for placement in asource of arterial blood, such as the aorta, the left ventricle or afemoral artery, and an outlet end having at least one conduit configuredto be placed in a renal artery. The catheter includes a lumen throughwhich arterial blood passes directly into a renal artery. The conduitmay include means for engaging an interior surface of the renal arteryto retain the conduit in position, and may comprise an occluder thatreduces backflow of blood exiting the conduit into the abdominal aorta.The catheter preferably is configured to permit percutaneous,transluminal implantation.

In accordance with the principles of the present invention, highpressure blood passes through the lumen of the catheter during systoleand into the conduit disposed in the renal artery. It is expected thatblood passing through the catheter will have a higher pressure andhigher flow rate than blood reaching the renal artery via the abdominalaorta. This in turn is expected to improve renal function, withoutadministering systemic doses of drugs to improve renal function or renalblood flow. The enhanced renal blood flow is expected to provide aproportional increase in renal function, thereby reducing fluidretention.

In alternative embodiments, the catheter may include first and secondconduits for perfusing both kidneys, a one-way valve disposed in thelumen to prevent backflow of blood in the lumen during diastole or amechanical pump to further enhance the flow of blood through the lumen.Still other embodiments of the catheter may include a drug infusionreservoir that injects a low dose of a drug, e.g., a diuretic orvasodilator, into blood flowing through the lumen, so that thedrug-infused blood passes directly into the kidneys. Still furtherembodiments may comprise separate catheters to perfuse the left andright kidneys, or may draw arterial blood from a peripheral vessel usingan external pump.

Methods of implanting the apparatus of the present invention also areprovided.

BRIEF DESCRIPTION OF THE DRAWINGS

Further features of the invention, its nature and various advantageswill be more apparent from the accompanying drawings and the followingdetailed description of the preferred embodiments, in which:

FIG. 1 is a partial sectional view of a human circulatory system havingapparatus constructed in accordance with the present invention implantedtherein;

FIG. 2 is a side view of an illustrative embodiment of the apparatus ofthe present invention;

FIG. 3 is an alternative embodiment of the apparatus of FIG. 2 includinga one-way valve, a blood pump and a drug infusion device;

FIG. 4 is a detailed perspective view of an occluder employed on theoutlet end of the catheter of FIG. 2; and

FIGS. 5A and 5B are partial sectional views depicting an illustrativemethod of implanting the catheter of FIG. 2.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides a catheter that may be implanted inpatients suffering from congestive heart failure (“CHF”) to improverenal blood flow and renal function. In accordance with the principlesof the present invention, it is expected that by passing blood from theleft ventricle directly to the renal arteries during systole, the bloodpressure and flow rate in the kidneys will be increased, resulting inenhanced renal function.

Referring to FIGS. 1 and 2, a first illustrative embodiment of apparatusconstructed in accordance with the principles of the present inventionis described. Catheter 10 comprises hollow flexible tube having inletend 11 and outlet end 12. Inlet end 11 includes distal hole 13 andlateral holes 14 that communicate with lumen 15 within catheter 10.Outlet end 12 comprises first and second branch conduits 16 and 17,respectively. Catheter 10 preferably comprises a flexible biocompatiblematerial, such as polyurethane, silicone, or polyethylene.

First branch conduit 16 includes outlet port 18 that communicates withlumen 15, and expandable occluder 19. Likewise, second branch conduit 17includes outlet port 20 that communicates with lumen 15, and expandableoccluder 21. First and second branch conduits 16 and 17 optionally mayinclude radio-opaque marker bands 22 near outlet ports 18 and 20,respectively, to assist in implanting catheter 10.

As depicted in FIG. 1, catheter 10 is implanted in circulatory system Cso that inlet end 11 is disposed in left ventricle LV or in the vicinityof aortic root AR, while first and second branch conduits 16 and 17,respectively, are disposed in renal arteries RA. Occluders 19 and 21,described in greater detail hereinafter, engage the walls of the renalarteries and retain first and second branch conduits 16 and 17,respectively in position. The occluders also serve to prevent backflowof high pressure blood exiting through outlet ports 18 and 20 fromflowing backwards into abdominal aorta AA. Accordingly, blood enteringcatheter 10 via distal hole 13 and lateral holes 14 during systolepasses directly into renal arteries RA and kidneys K through lumen 15,thereby enhancing renal blood flow and renal function.

Referring now to FIG. 3, an alternative embodiment of the apparatus ofthe present invention is described. Catheter 30 is similar inconstruction to catheter 10 of FIG. 1, and includes hollow flexible tubehaving inlet end 31 and outlet end 32. Inlet end 31 includes distal hole33 and lateral holes 34 that communicate with lumen 35. Outlet end 32comprises branch conduit 36 having outlet port 37 configured to beplaced in one of the patient's renal arteries. In this embodiment, theoccluder of the embodiment of FIG. 2 is omitted and instead the diameterof the branch conduit 36 is selected to provide a close fit with therenal artery. Engagement means, such as small ribs or barbs 38 also maybe disposed on the exterior surface of branch conduit 36 to retain thebranch conduit in the renal artery.

Because the renal arteries may branch from the abdominal aorta atdifferent levels, the catheter of FIG. 3 advantageously permits separatecatheters to be used to each perfuse only a single kidney. In addition,the inlet end of catheter 30 may be configured to be placed in aperipheral vessel rather than the left ventricle.

Catheter 30 further optionally comprises any one or more of thefollowing components: one-way valve 42, blood pump 43 or drug infusiondevice 44. While catheter 30 illustratively includes all three of theforegoing components, it is to be understood that any combination ofsuch components advantageously may be employed.

One-way valve 42, if provided, is configured to open during systole topermit blood to flow through lumen 35 from left ventricle LV towards therenal artery RA, but closes during diastole to prevent the leftventricle from drawing blood in the opposite direction.

Blood pump 43, if provided, may comprise an implantable blood pump, suchas are known in the art, and serves to enhance renal blood flow in thosepatients suffering from severe cardiac dysfunction. Alternatively, wherethe inlet end of catheter 30 is configured to be placed in a peripheralvessel, blood pump 30 advantageously may comprise an external bloodpump, such as are known in the art.

Drug infusion device 44, if provided, preferably comprises animplantable infusion device, such as are known in the art (e.g., forchelation therapy), and periodically infuses low doses of therapeuticagents into blood flowing through lumen 35. Because the infused drugsare delivered directly into the kidneys, smaller doses may be employed,while achieving enhanced therapeutic action and fewer side-effects.

With respect to FIG. 4, an illustrative embodiment of occluder 50suitable for use with the catheter of FIGS. 1 and 2 is described. In oneembodiment, occluder 50 comprises a low density, biocompatiblesponge-like material that may be compressed to a small thickness, andthat absorbs and expands when exposed to body fluid. In particular,occluder 50 preferably is compressed to a small thickness and thenmounted on the branch conduit so that, when the occluder is deployed ina renal artery, it swells and engages the interior of the renal artery.

Occluder 50 therefore serves to retain the branch conduit in position ina renal artery, and also reduces backflow of blood from the renal arteryinto the abdominal aorta. Alternatively, occluder 50 may comprise aninflatable member that is inflated and then sealed via a lumen (notshown) extending out of the patient's femoral artery. As a yet furtheralternative, occluder 50 may comprise a self-expanding hydrogel materialthat swells when exposed to body fluids to accomplish the functionsdescribed hereinabove.

While occluder 50 of FIG. 4 illustratively has an annular shape, itshould be understood that other shapes may be employed. For example,occluder 50 may be configured to only partially surround the branchconduit, and may provide only a partial seal with the interior surfaceof the renal artery. For example, depending upon the relative sizes ofthe branch conduit and the renal artery, and how far the branch conduitextends into the renal artery, occluder 50 may be omitted altogether.

Referring now to FIGS. 1, 5A and 5B, percutaneous, transluminalimplantation of the apparatus of FIG. 2 is described. First, guidewire100 is inserted in a retrograde manner through abdominal aorta AA via anaccess site in femoral artery FA until the tip of the guidewire isdisposed in the left ventricle, e.g., as determined by fluoroscopy.Catheter 10 is then advanced along guidewire 100, for example, using apush tube (not shown) disposed on guidewire 100, with first and secondbranch conduits 16 and 17 folded side-by-side. Filament 110 is loopedthrough a small opening at the bifurcation of the first and secondbranch conduits 16 and 17, so that the free ends 110 a and 110 b of loop110 may be manipulated by the surgeon.

As depicted in FIG. 5A, catheter 10 is pushed in a distal direction sothat outlet ports 18 and 20 of outlet end 12 clear the renal arteries,and guidewire 100 is withdrawn. Filament 110 then is pulled in theproximal direction so that the ends of the first and second branchconduits move into renal arteries RA, as illustrated in FIG. 5B. Strand55 of an elastic, high strength material, such as a nickel-titaniumalloy, may be embedded in the wall of catheter 10 in the bifurcation toensure that the first and second conduits open outwardly when catheter10 is pulled in a proximal direction by filament 110.

Once the position of first and second branch conduits 16 and 17 isconfirmed, for example, by observing the location of radio-opaquemarkers 22 (see FIG. 2) with a fluoroscope, occluders 19 and 21 expandto engage the interior surfaces of the renal arteries. Expansion of theoccluders may be accomplished either by holding the occluders in placewhile they expand (if self-expanding) or, if the occluders areinflatable, by injecting a suitable inflation medium.

Filament 110 then may be pulled completely through the opening in thebifurcation of catheter 10, leaving catheter 10 implanted in position.It is: expected that the opening needed to accommodate filament 110 willresult in negligible loss of blood through the opening once filament 110has been withdrawn. Alternatively, or in addition, additional guidewires(not shown) may be disposed through first and second branch conduits toassist in placing the first and second branch conduits in renal arteriesRA.

The foregoing methods may be readily adapted to implant two catheters ofthe type illustrated in FIG. 3, so that the branch conduit of eachcatheter perfuses a separate kidney. In addition, for acute treatment ofCHF, the catheter of FIG. 3 (including an external blood pump) may beplaced so that the inlet end is disposed in a patient's femoral artery,and the outlet end is disposed in one of the patient's renal arteries.

While preferred illustrative embodiments of the invention are describedabove, it will be apparent to one skilled in the art that variouschanges and modifications may be made therein without departing from theinvention, and the appended claims are intended to cover all suchchanges and modifications that fall within the true spirit and scope ofthe invention.

1. A method for affecting a renal system in a patient, comprising:locally delivering a fluid agent substantially only into a plurality ofrenal arteries associated with a plurality of ostia having uniquerespective positions along an abdominal aorta wall in a patient: whereinthe renal function of each of two kidneys is affected with a locallydelivered fluid agent; and wherein the fluid agent is locally deliveredinto the plurality of renal arteries substantially simultaneously. 2.The method of claim 1, wherein the local delivery of the fluid agentfurther comprises: positioning a fluid agent delivery device within eachof the plurality of renal arteries.
 3. The method of claim 1, furthercomprising: positioning a first conduit within a first renal artery;positioning a second conduit within a second renal artery; anddelivering the volume of fluid agent simultaneously to each of the firstand second renal arteries via the first and second conduits,respectively.
 4. The method of claim 2 further comprising: enhancingrenal function of each of two kidneys of the patient with the fluidagent locally delivered into the two or more renal arteries.
 5. Themethod of claim 1, wherein the local delivery of fluid agent into theone or more renal arteries comprises: locally delivering a volume ofdiuretic fluid agent into the one or more renal arteries.
 6. The methodof claim 5, wherein the local delivery of diuretic fluid agent into theone or more renal arteries comprises: locally delivering a volume offurosemide into the one or more renal arteries.
 7. The method of claim5, wherein the local delivery of diuretic fluid agent into the one ormore renal arteries comprises: locally delivering a volume of thiazideinto the one or more renal arteries.
 8. The method of claim 1, whereinthe local delivery of fluid agent into the one or more renal arteriescomprises: locally delivering a volume of vasopressor into the one ormore renal arteries.
 9. The method of claim 8, wherein the localdelivery of vasopressor into the one or more renal arteries furthercomprises:
 10. The method of claim 1, wherein the local delivery offluid agent into the one or more renal arteries comprises: locallydelivering a volume of vasodilator into the one or more renal arteries.11. The method of claim 1, further comprising: substantially enhancingrenal function with the local delivery of the fluid agent into the oneor more renal arteries without providing a sufficiently high systemicdose to cause substantial systemic side-effects.
 12. The method of claim1, further comprising: allowing aortic blood to flow across theplurality of renal artery ostia and into downstream circulation whilelocally delivering the fluid agent into the plurality of renal arteries.13. A method for treating a renal system in a patient, comprising:positioning a first conduit within a first renal artery; positioning asecond conduit within a second renal artery; and locally delivering avolume of a fluid agent simultaneously to each of the first and secondrenal arteries via the first and second conduits, respectively;enhancing the renal function of each of two kidneys with the volume offluid agent being delivered; and wherein the volume of fluid agentcomprises a diuretic, a vasopressor, or a vasodilator.